Elisabeth L.
Process Manager DSP MSAT Commercial
Experience
Process Manager DSP MSAT Commercial
- 1 year of experience as Process Manager DSP MSAT Commercial in change control and CPV
- document review
- product quality review
- batch record review
- CMC
- dossier Module 2.3 and 3
- change control
Ulm, Germany
Project Manager
- coordination, creation and processing of change control requests
- review of dossiers (Module 2.3 and Module 3)
- preparation of change notifications (variations)
- revision of product information texts (labelling)
- management and maintenance of document management systems
- execution of batch record review
- execution of product quality review
Reference Biopharmaceutical Quality Assurance
- 4 years of experience as Reference Biopharmaceutical Quality Assurance in change control, batch record review, and site RA
- document review
- product quality review
- batch record review
- CMC
- dossier Module 2.3 and 3
- change control
Reference Regulatory Affairs
- 9 years of experience as Reference Regulatory Affairs in dossier life cycle management, CMC and labelling
- document review
- product quality review
- batch record review
- CMC
- dossier Module 2.3 and 3
- change control
Summary
communication skills
detail-oriented work style
analytical thinking
problem-solving skills
adaptability and ability to prioritize
flexible
coordination, creation and processing of change control requests
review of dossiers (Module 2.3 and Module 3)
preparation of change notifications (variations)
revision of product information texts (labelling)
management and maintenance of document management systems
execution of batch record review
execution of product quality review
Languages
German
NativeEnglish
IntermediateEducation
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M.D.R.A. · Drug Regulatory Affairs
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Bachelor · Pharmaceutical Engineering
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